Mental HealthProvectus Pharmaceuticals To Offer Compassionate Use Of PV-10 For Non-Visceral Indications In Cancer Patients
Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has begun a compassionate use program for PV-10 and has made the agent, which is in development as a therapeutic agent for a broad spectrum of cancers, available for select cancer patients.
Initially, the compassionate use program will only be available for cancer indications that do not involve visceral organs and are not subject to enrollment in ongoing clinical trials. These indications include certain breast cancers, basal cell carcinoma, squamous cell carcinoma, certain head and neck cancers and melanoma. Provectus has begun its compassionate program for PV-10 in certain Australian "Centers of Excellence," including Sydney, Brisbane and Adelaide, and will expand it to the United States in coming months. The Australian program is under the guidelines of the Therapeutic Goods Administration"s Special Access Scheme, while the U.S. program is expected to be under the FDA"s regulations covering Treatment Use of an investigational new drug. Interested parties are encouraged to visit Provectus" website, http://www.pvct.com, where details on the compassionate use program and additional information will be posted in the near future. Compassionate use programs provide experimental therapeutics to patients prior to final FDA approval.
Dr. Kelly McMasters, a preeminent physician and investigator who is a member of Provectus" Board of Directors and head of its Scientific Advisory Board, will advise the Company on candidates for the program who might be safely helped by PV-10. "The potential for PV-10 to successfully treat metastatic melanoma, which has already been shown in humans, warrants its further use for melanoma and for other life-threatening scenarios on a compassionate use basis," said Dr. McMasters. Provectus is currently completing its Phase 2 clinical trial of PV-10 as a therapy for metastatic melanoma and has completed Phase 1 clinical testing of PV-10 for the treatment of recurrent breast carcinoma.
"We decided to initiate this program as we have had a continuing large number of requests by physicians and patients to make PV-10 available on a compassionate basis," said Craig Dees, Ph.D., CEO of Provectus. "Preliminary analysis of interim Phase 2 results from our melanoma clinical trial suggests that we can safely provide PV-10 for treatment of selected cancer patients, and that the agent has potential to benefit some of these patients. Knowing this information, we believe the ethical choice is to make the drug available on a compassionate use basis."
Provectus Pharmaceuticals, Inc.